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出境医 / 临床实验 / Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey. (PolSenior2)

Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey. (PolSenior2)

Study Description
Brief Summary:
The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland.

Condition or disease Intervention/treatment
Aging Disorder Age Problem Healthy Aging Immunity Disorders Frailty Syndrome Behaviors, Health Health Care Utilization Other: medical history, blood and urine tests

Detailed Description:

One of the goals is assessing the prevalence and control of age-related diseases and of the "geriatric giants" (immobility, instability, incontinence, sensory deficiency, cognition and mood disorders) which lead to frailty, disability and dependence. Monitoring of health status, health behaviors and identifying socio-economic factors favoring successful aging will be significant. As the polypragmasy and adverse drug reactions remain a significant issue in the geriatric care, pharmacotherapy and medical adherence will also be examined.

The additional purpose of the study is to evaluate the utilization and access to health care and social services in respect to needs for assistance and long-term care, as well as the level and different forms of these needs.

The project is planned as a cross-sectional survey of representative sample of 6000 people aged 60 years and over. The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, anthropometric and blood pressure measurements and laboratory tests. The data are collected by well-trained nurses during three visits at respondents homes.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
60 - 65 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

65 - 69 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

70 - 74 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

75 - 79 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

80 - 84 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

85 - 89 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

≥90 years
Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.

Outcome Measures
Primary Outcome Measures :
  1. Functional status as assessed by Vulnerable Elders Survey-13 [ Time Frame: baseline ]
    The Vulnerable Elders Survey-13 (VES-13) is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.

  2. Functional status as assessed by Instrumental Activity of Daily Living [ Time Frame: baseline ]
    This will be assessed using the Instrumental Activity of Daily Living (IADL-Lawton) instrument. IADL evaluates independent living skills. Each activity has specific level of participation that can be selected. Scores range from 0 (low function, dependent) to 8 points (high function, independent).

  3. Functional status as assessed by Activity of Daily Living Index [ Time Frame: baseline ]
    This will be assessed using the Activity of Daily Living (ADL-Katz Index) instrument. ADL evaluates functional status as a measurement of the patient's ability to perform activities of daily living. Each activity is rated as being completed independently or not. Scores range is 0-6 points, higher score is better.

  4. Mood deterioration incidence [ Time Frame: baseline ]
    The Geriatric Depression Scale (GDS) is a 15-item self-report assessment designed specifically to identify symptoms of depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past 2 weeks. The score 5 and more suggests the suspicion of depression, higher scores indicate more severe depressive syndrome. The final diagnosis of depression needs clinical assessment.

  5. Cognitive functions as assessed by the Mini Mental State Examination [ Time Frame: baseline ]
    The Mini Mental State Examination (MMSE) investigates specific cognitive functions. Scale range: 0-30. The score 23 and below indicates significant deterioration of cognitive functions and dementia. Score between 24-27 indicates mild cognitive impairment. Normal score ranges between 28-30.

  6. Cognitive functions as assessed by Clock Drawing Test [ Time Frame: baseline ]
    The Clock Drawing Test is a test used for the assessment of cognitive impairment based on sketches of a clock completed by a patient. The assessment is based on identifying abnormalities in the drawings, which may include poor number positioning, omission of numbers, incorrect sequencing, missing clock hands and the presence of irrelevant writing. According to Sunderland the score is: 0-10. Higher score indicates normal cognitive functions.

  7. Comorbidities incidence [ Time Frame: baseline ]
    the prevalence of comorbidities

  8. Nutritional status assessed by the Mini Nutritional Assessment questionnaire (MNA) [ Time Frame: baseline ]
    The MNA is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The Screening score(max. 14 points) is 12-14 points indicates "Normal nutritional status", 8-11 points indicates "At risk of malnutrition", 0-7 points indicates "Malnourished". For the full assessment there are proposed scores: 24 pts and more "Normal nutritional status"; 23,5-17 "At risk of malnutrition"; below 17 - malnourished"

  9. Sarkopenia incidence [ Time Frame: baseline ]
    The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).


Secondary Outcome Measures :
  1. Number of drugs taken [ Time Frame: baseline ]
    assessement of pharmacotherapy and polypragmasy

  2. Medical care availability [ Time Frame: five years back from baseline ]
    number of hospitalizations and of outpatients visits in last five years

  3. Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE) [ Time Frame: baseline ]
    The WHOQOL-AGE has been designed and validated to measure quality of life older adults. It provides a single score that ranges on a 0-100 scale, with higher scores indicating higher quality of life.

  4. Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index [ Time Frame: baseline ]
    The Pittsburgh Sleep Quality Index has been designed and validated to assess the presence of sleep disorders. It includes 19 questions that combine to evaluate 7 components of sleep, each evaluated from 0 to 3 (0 = no difficulty, 3 = severe difficulty). A total score greater than 5 indicates a sleep disorder.

  5. Alcohol abuse assessment [ Time Frame: baseline ]
    Alcohol abuse will be assessed using the Short Michigan Alcohol Screening (SMASM). This 10 item inventory characterizes behavior associated with alcoholism, the higher the score, the greater the severity of alcoholism in a respondent.

  6. Physical activity assessmed by the Seven-Day Recall Physical Activity Questionnaire (PAR) [ Time Frame: baseline ]
    Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. Low time span (low number of minutes) spent on physical activity suggest low level of it and is one of significant symptoms of frailty syndrome.

  7. Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS) [ Time Frame: baseline ]
    measurement by the Pain Assessment Scale (PAS)

  8. Presence and severity of chronic pain assessmed by the Visual Analog Scale (VAS) [ Time Frame: baseline ]
    VAS is a self-assessed maximum pain reported using a 0-100 mm visual analog scale, where 100 signifies maximum pain.


Biospecimen Retention:   Samples With DNA
36 ml of whole blood and 20 ml of urine samples

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The research population is assumed to include 6000 individuals in seven equivalent age cohorts (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-84 years, 85-89 years, 90+ years old) with equal representation of males and females in each of them.

Research participants were randomly recruited in a stratified, proportional draw. The pattern for respondent selection was designed to obtain a population representative for Polish old citizens.

Criteria

Inclusion Criteria:

  • over 60 years of age,
  • randomly selected from database of all Polish citizens,
  • consent to participate in the study.

Exclusion Criteria:

  • under 60 years of age,
  • no consent to participate in the study.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Tomasz R. Zdrojewski, MD, Prof +48 58 3491975 tz@gumed.edu.pl
Contact: Lukasz Wierucki, MD, PhD +48583491975 wierucki@gumed.edu.pl

Locations
Layout table for location information
Poland
Medical University of Gdańsk Recruiting
Gdańsk, Poland
Contact: Tomasz R. Zdrojewski, MD, Prof    +48 58 3491975    tz@gumed.edu.pl   
Contact: Lukasz Wierucki, MD, PhD    +48 58 3491975    wierucki@gumed.edu.pl   
Sponsors and Collaborators
Medical University of Gdansk
Ministry of Health, Poland
Medical University of Silesia
Jagiellonian University
International Institute of Molecular and Cell Biology in Warsaw
SGH Warsaw School of Economics
Medical University of Lodz
National Institute of Public Health-National Institute of Hygiene
Investigators
Layout table for investigator information
Principal Investigator: Tomasz R. Zdrojewski, MD, Prof Medical University of Gdansk, Poland
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 19, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
  • Functional status as assessed by Vulnerable Elders Survey-13 [ Time Frame: baseline ]
    The Vulnerable Elders Survey-13 (VES-13) is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.
  • Functional status as assessed by Instrumental Activity of Daily Living [ Time Frame: baseline ]
    This will be assessed using the Instrumental Activity of Daily Living (IADL-Lawton) instrument. IADL evaluates independent living skills. Each activity has specific level of participation that can be selected. Scores range from 0 (low function, dependent) to 8 points (high function, independent).
  • Functional status as assessed by Activity of Daily Living Index [ Time Frame: baseline ]
    This will be assessed using the Activity of Daily Living (ADL-Katz Index) instrument. ADL evaluates functional status as a measurement of the patient's ability to perform activities of daily living. Each activity is rated as being completed independently or not. Scores range is 0-6 points, higher score is better.
  • Mood deterioration incidence [ Time Frame: baseline ]
    The Geriatric Depression Scale (GDS) is a 15-item self-report assessment designed specifically to identify symptoms of depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past 2 weeks. The score 5 and more suggests the suspicion of depression, higher scores indicate more severe depressive syndrome. The final diagnosis of depression needs clinical assessment.
  • Cognitive functions as assessed by the Mini Mental State Examination [ Time Frame: baseline ]
    The Mini Mental State Examination (MMSE) investigates specific cognitive functions. Scale range: 0-30. The score 23 and below indicates significant deterioration of cognitive functions and dementia. Score between 24-27 indicates mild cognitive impairment. Normal score ranges between 28-30.
  • Cognitive functions as assessed by Clock Drawing Test [ Time Frame: baseline ]
    The Clock Drawing Test is a test used for the assessment of cognitive impairment based on sketches of a clock completed by a patient. The assessment is based on identifying abnormalities in the drawings, which may include poor number positioning, omission of numbers, incorrect sequencing, missing clock hands and the presence of irrelevant writing. According to Sunderland the score is: 0-10. Higher score indicates normal cognitive functions.
  • Comorbidities incidence [ Time Frame: baseline ]
    the prevalence of comorbidities
  • Nutritional status assessed by the Mini Nutritional Assessment questionnaire (MNA) [ Time Frame: baseline ]
    The MNA is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The Screening score(max. 14 points) is 12-14 points indicates "Normal nutritional status", 8-11 points indicates "At risk of malnutrition", 0-7 points indicates "Malnourished". For the full assessment there are proposed scores: 24 pts and more "Normal nutritional status"; 23,5-17 "At risk of malnutrition"; below 17 - malnourished"
  • Sarkopenia incidence [ Time Frame: baseline ]
    The prevalence of sarcopenia will be assessed by analysis of grip strength (use of dynamometer).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
  • Number of drugs taken [ Time Frame: baseline ]
    assessement of pharmacotherapy and polypragmasy
  • Medical care availability [ Time Frame: five years back from baseline ]
    number of hospitalizations and of outpatients visits in last five years
  • Quality of life as assessed by the World Health Organization Quality of Life Age (WHOQOL-AGE) [ Time Frame: baseline ]
    The WHOQOL-AGE has been designed and validated to measure quality of life older adults. It provides a single score that ranges on a 0-100 scale, with higher scores indicating higher quality of life.
  • Quality and patterns of sleep assessmed by the Pittsburgh Sleep Quality Index [ Time Frame: baseline ]
    The Pittsburgh Sleep Quality Index has been designed and validated to assess the presence of sleep disorders. It includes 19 questions that combine to evaluate 7 components of sleep, each evaluated from 0 to 3 (0 = no difficulty, 3 = severe difficulty). A total score greater than 5 indicates a sleep disorder.
  • Alcohol abuse assessment [ Time Frame: baseline ]
    Alcohol abuse will be assessed using the Short Michigan Alcohol Screening (SMASM). This 10 item inventory characterizes behavior associated with alcoholism, the higher the score, the greater the severity of alcoholism in a respondent.
  • Physical activity assessmed by the Seven-Day Recall Physical Activity Questionnaire (PAR) [ Time Frame: baseline ]
    Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. Low time span (low number of minutes) spent on physical activity suggest low level of it and is one of significant symptoms of frailty syndrome.
  • Presence and severity of chronic pain assessmed by the Pain Assessment Scale (PAS) [ Time Frame: baseline ]
    measurement by the Pain Assessment Scale (PAS)
  • Presence and severity of chronic pain assessmed by the Visual Analog Scale (VAS) [ Time Frame: baseline ]
    VAS is a self-assessed maximum pain reported using a 0-100 mm visual analog scale, where 100 signifies maximum pain.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey.
Official Title Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide, Cross-sectional PolSenior2 Survey.
Brief Summary The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland.
Detailed Description

One of the goals is assessing the prevalence and control of age-related diseases and of the "geriatric giants" (immobility, instability, incontinence, sensory deficiency, cognition and mood disorders) which lead to frailty, disability and dependence. Monitoring of health status, health behaviors and identifying socio-economic factors favoring successful aging will be significant. As the polypragmasy and adverse drug reactions remain a significant issue in the geriatric care, pharmacotherapy and medical adherence will also be examined.

The additional purpose of the study is to evaluate the utilization and access to health care and social services in respect to needs for assistance and long-term care, as well as the level and different forms of these needs.

The project is planned as a cross-sectional survey of representative sample of 6000 people aged 60 years and over. The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, anthropometric and blood pressure measurements and laboratory tests. The data are collected by well-trained nurses during three visits at respondents homes.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
36 ml of whole blood and 20 ml of urine samples
Sampling Method Non-Probability Sample
Study Population

The research population is assumed to include 6000 individuals in seven equivalent age cohorts (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-84 years, 85-89 years, 90+ years old) with equal representation of males and females in each of them.

Research participants were randomly recruited in a stratified, proportional draw. The pattern for respondent selection was designed to obtain a population representative for Polish old citizens.

Condition
  • Aging Disorder
  • Age Problem
  • Healthy Aging
  • Immunity Disorders
  • Frailty Syndrome
  • Behaviors, Health
  • Health Care Utilization
Intervention Other: medical history, blood and urine tests
The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
Study Groups/Cohorts
  • 60 - 65 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
  • 65 - 69 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
  • 70 - 74 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
  • 75 - 79 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
  • 80 - 84 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
  • 85 - 89 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
  • ≥90 years
    Subjects were selected using a three stage stratified and proportional random sampling in seven equally size (n=850) age groups: 60-65, 65-69, 70-74, 75-79, 80-84, 85-89, 90+ years.
    Intervention: Other: medical history, blood and urine tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2019)
6000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • over 60 years of age,
  • randomly selected from database of all Polish citizens,
  • consent to participate in the study.

Exclusion Criteria:

  • under 60 years of age,
  • no consent to participate in the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tomasz R. Zdrojewski, MD, Prof +48 58 3491975 tz@gumed.edu.pl
Contact: Lukasz Wierucki, MD, PhD +48583491975 wierucki@gumed.edu.pl
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04026815
Other Study ID Numbers 6/5/4.2/NPZ/2017/1203/1257
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Tomasz Zdrojewski, Medical University of Gdansk
Study Sponsor Medical University of Gdansk
Collaborators
  • Ministry of Health, Poland
  • Medical University of Silesia
  • Jagiellonian University
  • International Institute of Molecular and Cell Biology in Warsaw
  • SGH Warsaw School of Economics
  • Medical University of Lodz
  • National Institute of Public Health-National Institute of Hygiene
Investigators
Principal Investigator: Tomasz R. Zdrojewski, MD, Prof Medical University of Gdansk, Poland
PRS Account Medical University of Gdansk
Verification Date July 2019